Advanced Cell Technology Receives Approval from Data Safety Monitoring Board (DSMB) to Initiate Treatment of Third Patient

  Advanced Cell Technology Receives Approval from Data Safety Monitoring Board
  (DSMB) to Initiate Treatment of Third Patient Cohort in All Three Clinical
  Trials

Also Receives DSMB Approval to Treat Additional Cohort of Patients with Better
                                    Vision

Business Wire

MARLBOROUGH, Mass. -- March 14, 2013

Advanced Cell Technology, Inc. ("ACT"; OTCBB: ACTC), a leader in the field of
regenerative medicine, announced today that the independent Data and Safety
Monitoring Board (DSMB) overseeing the Company’s three ongoing stem cell
clinical trials in the United States and Europe has authorized the Company to
move forward with enrolling and treating the patients in the next cohort of
each of the trials. Per each trial’s protocol, the first patient of “cohort 3”
will be injected with 150,000 human embryonic stem cell (hESC)-derived retinal
pigment epithelial (RPE) cells. This represents a fifty percent increase in
the dose of RPE cells as compared to the previously treated cohort of
patients. The first patients treated at this escalated dose will be evaluated,
with interim DSMB review after six weeks, at which time the determination to
continue treating additional patients at this dosage will be made.

Additionally, the DSMB has authorized the Company to proceed with treating
patients in the two U.S. trials as part of additional cohorts recently
approved by the FDA. In particular, the FDA approved the addition of two new
cohorts of four patients each – one cohort for each of the Stargardt’s Macular
Dystrophy (SMD) and dry age-related macular degeneration (dry AMD) trials –
which can include patients with better vision. The specific protocol for these
“cohort 2a” patients establishes eligibility for enrollment based on visual
acuity as good as 20/100. Previous patients enrolled in the trials have visual
acuity no better than 20/400 and ranging to patients whose visual acuity had
deteriorated to hand-motion only sight. In addition to establishing the safety
of the transplanted RPE cells, the opportunity to treat patients earlier in
the course of progression of these diseases improves the likelihood of
enrolling patients having a greater number of photoreceptors that, while
inactive due to loss of the native RPE layer, are dormant but able to be
rescued by the reestablishment of a functional RPE layer from the transplanted
cells. Enrollment of the additional patients as part of cohort 2a will be
simultaneous with enrollment of patients in the 150,000 cell dose cohort 3
patients.

“With DSMB approval now secured, we look forward to proceeding with the third,
higher-dosage cohort in all three trials in coming weeks, as well as
initiating a separate cohort, 2a, of patients who represent earlier stages of
these degenerative diseases,” commented Gary Rabin, chairman and CEO of ACT.
“Moreover, we anticipate that the added cohort 2a patients may not only shed
additional light on the safety and tolerability of our RPE cells, but offer us
the opportunity to gather anatomical and functional data that can be used to
help in the design and selection of endpoints for our eventual phase II
studies.”

The three clinical trials in the U.S. and Europe investigate hESC-derived RPE
cells for the treatment of dry AMD and SMD, both forms of macular
degeneration. These trials are prospective, open-label studies, designed to
determine the safety and tolerability of hESC-derived RPE cells following
sub-retinal transplantation into patients with dry AMD or SMD at 12 months,
the study’s primary endpoint. With the addition of the new cohort 2a patients,
each of the U.S. trials will now enroll a total of 16 patients across the
ascending dosage format of 50,000 to 200,000 RPE cells.

“We are pleased to receive the unanimous recommendation of the DSMB to
initiate the third, higher-dosage patient treatments in the US and EU trials
for Stargardt’s disease and dry AMD,” said Robert Lanza, M.D., chief
scientific officer of ACT. “In addition, we are excited by the prospects of
being able to work with better vision patients being enrolled in the 2a
cohort. We think this provides a unique opportunity to gain preliminary data
and insight from the treatment of patients that begin to resemble the early
and intermediate stage dry AMD and SMD patients we hope to be able to treat in
the next phase of these trials.”

Preliminary results from the U.S. Stargardt’s and dry AMD trials
werereportedinThe Lancetlast year.

Further information about patient eligibility for ACT’s dry AMD study and the
concurrent studies in the U.S. and the E.U. for SMD is available at
www.clinicaltrials.govwith the following Identifiers: NCT01344993 (dry AMD),
NCT01345006 (U.S. SMD) and NCT01469832 (E.U. SMD).

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying cellular
technology in the field of regenerative medicine. For more information, visit
http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating
results, future growth in research and development programs, potential
applications of our technology, opportunities for the company and any other
statements about the future expectations, beliefs, goals, plans, or prospects
expressed by management constitute forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. Any
statements that are not statements of historical fact (including statements
containing the words “will,” “believes,” “plans,” “anticipates,” “expects,”
“estimates,” and similar expressions) should also be considered to be
forward-looking statements. There are a number of important factors that could
cause actual results or events to differ materially from those indicated by
such forward-looking statements, including: limited operating history, need
for future capital, risks inherent in the development and commercialization of
potential products, protection of our intellectual property, and economic
conditions generally. Additional information on potential factors that could
affect our results and other risks and uncertainties are detailed from time to
time in the company’s periodic reports, including the report on Form 10-K for
the year ended December 31, 2012. Forward-looking statements are based on the
beliefs, opinions, and expectations of the company’s management at the time
they are made, and the company does not assume any obligation to update its
forward-looking statements if those beliefs, opinions, expectations, or other
circumstances should change. Forward-looking statements are based on the
beliefs, opinions, and expectations of the company’s management at the time
they are made, and the company does not assume any obligation to update its
forward-looking statements if those beliefs, opinions, expectations, or other
circumstances should change. There can be no assurance that the Company’s
clinical trials will be successful.

Contact:

Investors:
CEOcast, Inc.
James Young, 212-732-4300
or
Press:
ACT Corporate Communications
Bill Douglass, 646-450-3615
or
Russo Partners
Martina Schwarzkopf, Ph.D., 212-845-4292
 
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